exceed character length restrictions'mdicated. -. IRG: 2RR1 SRC(99) Received: 02/0 1/2005 1. TITLE OF PROJECT (Do not exceed 56 characters, including spaces and pun^iuaiujn./ General Clinical Research Center 2. RESPONSE TO SPECIFIC REQUEST FORAPPLICATIONS OR PROGRAMANNOUNCEMENT OR SOLICITATION IE! NO D YES (If "Yes, "state number and title) Number: Title: 3. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR New Investigator |^3 No l~1 Yes 3a. NAME (Last, first, middle) 3b. DEGREE(S) Kelch, Robert P. M.D. [unreadable] ', 3c. POSITION TITLE 3d. MAILING ADDRESS (Street, city, state, zip code) Principal Investigator General Clinical Research Center 3e. DEPARTMENT, SERVICE, LABORATORY,OR EQUIVALENT 1500 E. Medical Center Drive Internal Medicine Ann Arbor, Ml 48109-0108 3f. MAJOR SUBDIVISION Medical School 3g. TELEPHONE AND FAX (Area code, number and extension) E-MAILADDRESS: TEL: 734-936-8080 FAX: 734-936-4024 violet@umich.edu 4. HUMAN SUBJECTS 43.Research Exempt M No D Yes 5. VERTEBRATE ANIMALS IE! No D Yes RESEARCH |f .yes [unreadable]Exemption No / D N0 4b. Human Subjects 4c. NIH-defined PhaseIII 5a. If "Yes,' IACUC 5b. Animal welfare assuranceno. V| yes Assurance No. Clinical Trial approval Date FWA00004969 [X] No D Yes A3114-01 6. DATES OF PROPOSEDPERIOD OF 7. COSTS REQUESTEDFOR INITIAL 8. COSTS REQUESTED FORPROPOSED SUPPORT (month, day, year[unreadable]MM/DD/YY) BUDGET PERIOD PERIOD OFSUPPORT rrom Through 7a. Direct Costs ($) 7b. Total Costs ($) 8a. Direct Costs ($) 8b. Total Costs ($) 3/1/2006 2/28/2011 $6,543,962 $7,112,996 $34,472,530 $37,479,141 9. APPLICANT ORGANIZATION 10. TYPE OF ORGANIZATION Name The Regents of the University of Michigan Public: -> D Federal [unreadable]3 State D Local Address 3014 Fleming Private: -[unreadable] I I Private Nonprofit Ann Arbor, Ml 48109-1340 For-profit: -> I I General I I Small Business H] Woman-owned I I Socially and Economically Disadvantaged 11. ENTITY IDENTIFICATION NUMBER 1386006309A1 DUNS NO. 073133571 Institutional Profile File Number (if known) Congressional District 15th 12. ADMINISTRATIVE OFFICIAL TO BE NOTIFIED IF AWARD IS MADE 13. OFFICIAL SIGNING FOR APPLICANTORGANIZATION Name James Randolph Name James Randolph Title Senior Associate Director Title Senior Associate Director Address Division of Research Development and Administration Address pivision of Research Development and Admin. 3003 South State St., Room 1044 3003 South State Street, Room 1044 Ann Arbor, Ml 48109-1274 Ann Arbor, Ml 48109-1 274 Tel: (734)764-7242 FAX: (734)763-4053 Tel: (734)764-7242 FAX:(734)763-4053 E-Mail: nihjim@umich.edu E-Mail: nihjim@umich.edu 14. PRINCIPALINVESTIGATOR/PROGRAMDIRECTOR ASSURANCE: I certify that the SIGNATURE OF PI/PD NAMED IN 3a. DATE statements herein are true, complete and accurate to the best of my knowledge. I am (Inink. "Per" signature notaccaettfable.I i .-. aware that any false, fictitious, or fraudulent statements or claims may subject me to corinmdiuncatl,ocfivthil,eoprraodjemctinainsdtratotivperopveindaelttihees.reIqaugireed tporoagcrcespst repsoprotnssifibailigtyrafonrt itsheawscairednetdificas -7Z$%&^**- lH* a result of this application. 15. APPLICANT ORGANIZATION CERTIFICATION AND ACCEPTANCE: I certify that SIGNATURE OF OFFICIAL NAMKTIN 1 3. DATE taishceacewsptatrtdethmedeoanbstsligahareteirosenuinltoaorfceothmtrisupealy,pcwpolimtchapPtlieoutnbe.licaInHadmeacaltcwhuaSrraetertvhticoaettshaenteybrmefasltseao,nf dfmicytiotiknonduoistwi,olnoesrdfgirfeaa,uadgnuradlentt (I^nin^kier"^sig^na<ju^^jtat-=s/xje:m^ab_jis.) _^ '/,"/o^: statements or claims may subject me to criminal, civil, or administrative penalties. PHS 398 (Rev.05/01) Face Page Form Page 1 1